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An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Patients With Generalized Anxiety Disorder (AQUARIUS)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00266747
First received: December 16, 2005
Last updated: March 10, 2009
Last verified: March 2009
  Purpose

The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in patients with generalized anxiety disorder (GAD).The secondary objectives are to evaluate the efficacy of SR58611A on disability and quality of life in patients with GAD and to evaluate safety of SR58611A.


Condition Intervention Phase
Anxiety Disorders
Drug: SR58611A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Eight-Week,Dble-Blind,Placebo-Controlled, Multicenter Study With Paroxetine (20 mg q24) as Positive Control, Evaluating the Efficacy, Safety and Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Outpatients With Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.

Secondary Outcome Measures:
  • The main secondary outcomes are the changes from baseline to Day 56 of treatment in the CGI Severity of Illness Score, percentage of patients with HAM-A treatment response and change from baseline in the HAM-A somatic and psychic anxiety factor scores.

Enrollment: 366
Study Start Date: December 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Detailed Description:

The study is a multicenter, multicountry, randomized, parallel-group, double blind, placebo and paroxetine-controlled study consisting of three segments (A, B, and C). Segment A is a 1-week, placebo, single-blind period and Segment B is an 8-week, double blind period. All randomized patients must complete a post-study visit 1 week after intake of the last dose of study medication.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Out-patients, 18 to 65 years of age.
  • Patients suffering from generalized anxiety disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) plus GAD Module.
  • With a total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) ³ 20.
  • Having given voluntarily their written informed consent to participate in the study.
  • Able to comply with the protocol and follow written and verbal instructions.
  • For inclusion into Segment B of the study, patients must fulfill the following criteria:
  • All Segment A inclusion criteria.
  • Completion of a minimum of 3 and a maximum of 9 days of treatment in Segment A.
  • Not "placebo responders" (i.e., improvement £ 20 % on HAM-A total score between V1 and V2)

Exclusion Criteria:

  • Patients with a diagnosis of Major Depressive Disorder as defined by DSM-IV-TR within 6 months of study entry.
  • Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18 or higher at screening or baseline visits.
  • Patients having a moderate to high current risk for suicide.
  • Patients with other current anxiety disorder assessed with the MINI: agoraphobia, social phobia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, acute stress disorder.
  • Patients with a lifetime history according to the MINI of: bipolar disorders, psychotic disorders, antisocial personality disorder.
  • Patients with severe or unstable concomitant medical conditions according to the Investigator's judgment.
  • Females who are pregnant or lactating.
  • Female patients of childbearing potential must use an effective method of birth control during the entire study period.
  • Patients with positive test for any illicit drug included in the urine drug screen.
  • Participation in a clinical trial of an experimental therapy within 3 months prior to screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266747

Locations
Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Austria
Sanofi-Aventis Administrative Office
Vienna, Austria
Estonia
Sanofi-Aventis Administrative Office
Tallinn, Estonia
France
Sanofi-Aventis Administrative Office
Paris, France
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00266747     History of Changes
Other Study ID Numbers: EFC5893
Study First Received: December 16, 2005
Last Updated: March 10, 2009
Health Authority: South Africa: Medicines Control Council
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Sweden: Medical Products Agency

Keywords provided by Sanofi:
Anxiety
Anti-Anxiety Agents
Controlled Clinical Trial

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes
Amibegron
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014